The PPRU at Baylor College of Medicine (BCM)/ Texas Children's Hospital (TCH) is uniquely suited to provide a locus for the Conduct of studies in all aspects of pediatric pharmacology, from preclinical studies of investigational drugs to safety and efficacy studies of drugs already marketed. The unit is located in the nation's largest children's hospital, which has 451 in-patient beds and records more than 1.2 million patient encounters per year, drawn from a large and highly ethnically diverse population. In addition to contributing expertise in all 40 of its pediatric medical subspecialties. the BCM/TCH PPRU brings to the network extraordinary experience in the design of clinical pharmacology studies and the conduct of clinical trials. The program consists of: pharmacology laboratories with extensive expertise in pharmacokinetic (PK) modeling and a wide array of laboratory techniques used for drug measurement; pharmacokinetic, pharmacodynamic and pharmacogenetic studies; a unified, integrated Clinical Research Operations Unit infrastructure; a Regulatory Affairs Office, a Grants and Contracts Unit, and an Administrative Operations Group. The BCMITOH PPRU is staffed by board-certified and board-eligible pediatricians, pharmacologists, post doctoral fellows, clinical research nurses, pharmacists, data managers, protocol coordinators, regulatory affairs and quality assurance personnel, laboratory research assistants, a pediatric nurse practitioner, a research administrator and an administrative assistant. The BCMITCH PPRU is also the site of a comprehensive Training Program. During the current award period, the BCMITCH PPRU has developed a highly organized and collaborative program that has been active in all aspects of the PPRU Network including: accrual of patients to PPRU Network studies; initiation of investigator-initiated, industry-sponsored, and CR0 Network protocols; approval of 2 clinical research studies through the NICHD-PPRU supplemental funding awards program; collaboration in the development of two separate PPRU initiated RO1 grants; and, training of 3 pediatricians in clinical and developmental pharmacology. BCM/TCH PPRU investigators have had a major impact on the Network through Committee leadership and participation, and have significantly contributed to the Network's scientific activities. The BCMITCH PPRU is well-positioned and committed to helping achieve the goals of the PPRU Network.